Prostate Cancer Clinical Trial
Official title:
A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a
substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or
lycopene before surgery may be an effective treatment for prostate cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of
lycopene before surgery in treating patients who have stage I or stage II prostate cancer.
OBJECTIVES:
- Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on
intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients
with localized prostate cancer.
- Compare the effects of these nutritional supplements on increases in plasma levels and
tissue levels of these agents in these patients.
- Compare the effects of these nutritional supplements on changes in surrogate markers of
disease progression (e.g., prostate-specific antigen levels) in these patients.
- Compare the effects of these nutritional supplements on changes in serum steroid
hormones, estradiol, and free testosterone in these patients.
- Compare the magnitude of these changes in patients treated with these nutritional
supplements vs patients in the control group.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial
neoplasia. Patients are randomized to 1 of 7 treatment groups.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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